A randomized, double-blind, single-dose study (LAVENDER) to assess the safety, tolerability, pharmacokinetics, and immunogenicity of a combined infusion of ABP 980 and pertuzumab in healthy subjects.

ABSTRACT:

Purpose

ABP 980 (KANJINTI^™) is a biosimilar to reference product HERCEPTIN^® (trastuzumab RP). The goal of this study was to characterize the safety, tolerability, and immunogenicity of ABP 980 plus pertuzumab (PERJETA^®) when co-administered in a single infusion bag in healthy subjects.

Methods

This randomized, double-blind, single-dose, 2-arm, parallel-group study (LAVENDER Study) evaluated an intravenous (IV) infusion of ABP 980 (6 mg/kg) plus pertuzumab (420 mg) combined in a single infusion bag relative to an IV infusion of trastuzumab RP (6 mg/kg) plus pertuzumab (420 mg) combined in a single infusion bag given over 60 min. The subjects were followed for 92 days post dosing.

Results

A total of 42 subjects were enrolled in the study

SUBMITTER: Hanes V 

PROVIDER: S-EPMC8484235 | biostudies-literature | 2021 Nov

REPOSITORIES: biostudies-literature